Class 2 Device Recall Slotted Mallet

• Date Initiated by Firm: July 21, 2021
• Create Date: October 16, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0122-2022
• Recall Event ID: 88585
• Product Classification: Mallet - Product Code HXL
• Product: MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194 www.m-p-r.com MPR-1120-1000 (01)00840001405868
• Code Information: Model Number: MPR-1120-1000, Lot Number: 200911-1-1
• FEI Number: 1000139815
• Recalling Firm/ Manufacturer: Implant Resource Inc; 917 Lone Oak Rd Ste 1000; Eagan MN 55121-2266
• For Additional Information Contact: Ben Hanson; 952-277-1257
• Manufacturer Reason for Recall: Potential for mallet head to become separated from mallet handle. There is also significant deformations on striking surface that were not expected
• FDA Determined Cause: Device Design
• Action: Customers were initially contacted via email on 07/21/2021 to initiate the return of affected devices. A formal letter was sent to customers on 09/03/2021 via UPS. Instructions included to review the notification and ensure affected personnel are notified of the recall, immediately locate and quarantine any affected product in inventory, and to immediately return any affected product to Medical Products Resource.
• Quantity in Commerce: 6 units
• Distribution: US distribution to Florida and New Hampshire
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.